MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML VET U40 29GA 12.7MM 10BAG

Model Number 323000

Device Problems Volume Accuracy Problem (1675); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that scale marking error was found during use with a syringe 0.3ml vet u40 29ga 12.7mm 10bag.The following information was provided by the initial reporter, "pet owner reported, she is finding syringes that are not horizontal, there bent slightly making it difficult to know if she is drawing correct dosage.Stated, some of the syringes scale markings are not uniformed.(zero marking starting in different area on barrel) she purchased two boxes about a week ago and experiencing the issues in both.".

Event Description

It was reported that scale marking error was found during use with a syringe 0.3ml vet u40 29ga 12.7mm 10bag.The following information was provided by the initial reporter, "pet owner reported, she is finding syringes that are not horizontal, there bent slightly making it difficult to know if she is drawing correct dosage.Stated, some of the syringes scale markings are not uniformed.(zero marking starting in different area on barrel) she purchased two boxes about a week ago and experiencing the issues in both.".

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned as of 7 january 2020 therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9126665.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200822422, 200822330] noted that did not pertain to the complaint.H3 other text : see h.10.

• Brand Name: SYRINGE 0.3ML VET U40 29GA 12.7MM 10BAG
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9513014
• MDR Text Key: 181806340
• Report Number: 1920898-2019-01467
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: 9126665
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other